Senior Design Verification Lead

Job Title: Senior Design Verification Lead – Drug Substance Manufacturing

Location: Lebanon, IN

Experience: 10+ Years

Mode of interview: 2 Virtual Interviews (relocation candidates are okay)

Preferred Pharma and Site Expansion experience

Update:

·        Heavy P&ID experience, work on P&ID design reviews, review P&ID’s line by line.  Ability to describe design verification from start to finish.

·        Experience with early design process, detail design experience and specific examples around detail design previous work.  Ability to work pre-conceptual design experience is a must.

·        Must have vendor experience, managing scope and quality expectations and technical alignment.  Align schedules with FAT and SAT testing to ensure specs are in line with site team.

Job description:

·        The Design Verification Lead is responsible for ensuring that all new and modified equipment, systems, utilities, and processes within the new site drug substance manufacturing facility meet their intended design requirements and regulatory expectations.

Key Responsibilities

1. Design Verification Program Leadership

Develop, implement, and maintain the Design Verification (DV) framework for facility, equipment, automation, and process changes.

Ensure alignment with GMP, ICH Q8–Q11, FDA, EMA, and ISPE Baseline Guide expectations for biologics manufacturing.

2. User Requirements & Functional Specifications

Lead cross‑functional teams to translate process needs into User Requirements Specifications (URS).

Review and challenge vendor Functional Design Specs (FDS), Detailed Design Specs (DDS), and engineering documentation for completeness and compliance.